<?xml version="1.0" encoding="ISO-8859-1"?>
<!DOCTYPE ODM SYSTEM "odm1-1-0.dtd">
<ODM Description="CDISC ODM version 1.1.0 format" FileType="Transactional" Granularity="All" FileOID="987-654-321" CreationDateTime="2002-04-29T11:07:23-05:00">
	<Study OID = "123-456-789">
		<GlobalVariables>
			<StudyName>CDISC Connect-A-Thon Test Study III</StudyName>
			<StudyDescription>This file contains test data for the CDISC Connect-A-Thon event scheduled for the DIA 38th annual meeting in Chicago.</StudyDescription>
			<ProtocolName>CDISC-123-456-789</ProtocolName>
		</GlobalVariables>
		<BasicDefinitions>
			<MeasurementUnit OID = "MU.KG" Name = "Kilogram">
				<Symbol>
					<TranslatedText xml:lang = "en">English: Kilogram</TranslatedText>
					<TranslatedText xml:lang = "fr">French: Kilogram</TranslatedText>
				</Symbol>
			</MeasurementUnit>
			<MeasurementUnit OID = "MU.LB" Name = "Pound">
				<Symbol>
					<TranslatedText xml:lang = "en">English: Pound</TranslatedText>
					<TranslatedText xml:lang = "fr">French: Pound</TranslatedText>
				</Symbol>
			</MeasurementUnit>
			<MeasurementUnit OID = "MU.DPML" Name = "dilberts/ml">
				<Symbol>
					<TranslatedText xml:lang = "en">dilberts/ml</TranslatedText>
				</Symbol>
			</MeasurementUnit>
			<MeasurementUnit OID = "MU.FPML" Name = "filberts/ml">
				<Symbol>
					<TranslatedText xml:lang = "en">filberts/ml</TranslatedText>
				</Symbol>
			</MeasurementUnit>
		</BasicDefinitions>
		<MetaDataVersion OID = "v1.1.0" Name = "Version 1.1.0">
			<Protocol>
				<StudyEventRef StudyEventOID = "SE.VISIT0" OrderNumber = "1" Mandatory = "Yes"/>
				<StudyEventRef StudyEventOID = "SE.VISIT1" OrderNumber = "2" Mandatory = "Yes"/>
			</Protocol>
			<StudyEventDef OID = "SE.VISIT0" Name = "Pre-treatment" Repeating = "No" Type = "Scheduled" Category = "PreTreatment">
				<FormRef FormOID = "FORM.DEMOG" OrderNumber = "1" Mandatory = "No"/>
				<FormRef FormOID = "FORM.DRUGPHRM" OrderNumber = "2" Mandatory = "No"/>
				<FormRef FormOID = "FORM.PHARMVIT" OrderNumber = "3" Mandatory = "No"/>
				<FormRef FormOID = "FORM.VITPHYEX" OrderNumber = "4" Mandatory = "No"/>
			</StudyEventDef>
			<StudyEventDef OID = "SE.VISIT1" Name = "Post-treatment" Repeating = "No" Type = "Scheduled" Category = "PostTreatment">
				<FormRef FormOID = "FORM.AE" OrderNumber = "1" Mandatory = "No"/>
				<FormRef FormOID = "FORM.CONMED" OrderNumber = "2" Mandatory = "No"/>
				<FormRef FormOID = "FORM.VITPHYEX" OrderNumber = "3" Mandatory = "No"/>
			</StudyEventDef>
			<FormDef OID = "FORM.AE" Name = "Adverse Events" Repeating = "No">
				<ItemGroupRef ItemGroupOID = "IG.AE" OrderNumber = "1" Mandatory = "No"/>
			</FormDef>
			<FormDef OID = "FORM.CONMED" Name = "Concom Meds" Repeating = "No">
				<ItemGroupRef ItemGroupOID = "IG.CONMED" OrderNumber = "1" Mandatory = "No"/>
			</FormDef>
			<FormDef OID = "FORM.DEMOG" Name = "Demography" Repeating = "No">
				<ItemGroupRef ItemGroupOID = "IG.DEMOG" OrderNumber = "1" Mandatory = "No"/>
			</FormDef>
			<FormDef OID = "FORM.DRUGPHRM" Name = "Treatment Assignment" Repeating = "No">
				<ItemGroupRef ItemGroupOID = "IG.DRUG_TRT" OrderNumber = "1" Mandatory = "No"/>
			</FormDef>
			<FormDef OID = "FORM.PHARMVIT" Name = "Pharmacokinetics" Repeating = "No">
				<ItemGroupRef ItemGroupOID = "IG.PHARMO1" OrderNumber = "1" Mandatory = "No"/>
			</FormDef>
			<FormDef OID = "FORM.VITPHYEX" Name = "Physical Exam" Repeating = "No">
				<ItemGroupRef ItemGroupOID = "IG.PHYEX" OrderNumber = "1" Mandatory = "No"/>
			</FormDef>
			<ItemGroupDef OID = "IG.AE" Name = "Adverse Events" Repeating = "Yes" IsReferenceData = "No" SASDatasetName = "AE" Domain = "AE Domain" Origin = "AE Origin" Role = "AE Role" Comment = "AE Comment">
				<ItemRef ItemOID = "IT.TAREA" OrderNumber = "1" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PNO" OrderNumber = "2" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.SCTRY" OrderNumber = "3" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.F_STATUS" OrderNumber = "4" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.LINE_NO" OrderNumber = "5" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AETERM" OrderNumber = "6" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AESTMON" OrderNumber = "7" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AESTDAY" OrderNumber = "8" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AESTYR" OrderNumber = "9" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AESTDT" OrderNumber = "10" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AEENMON" OrderNumber = "11" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AEENDAY" OrderNumber = "12" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AEENYR" OrderNumber = "13" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AEENDT" OrderNumber = "14" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AESEV" OrderNumber = "15" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AEREL" OrderNumber = "16" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AEOUT" OrderNumber = "17" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AEACTTRT" OrderNumber = "18" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AECONTRT" OrderNumber = "19" Mandatory = "No"/>
			</ItemGroupDef>
			<ItemGroupDef OID = "IG.CONMED" Name = "Concom Meds" Repeating = "Yes" IsReferenceData = "No" SASDatasetName = "CONMED" Domain = "Conmed Domain" Origin = "Conmed Origin" Role = "Conmed Role" Comment = "Conmed Comment">
				<ItemRef ItemOID = "IT.R_DRUG" OrderNumber = "1" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.TAREA" OrderNumber = "2" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PNO" OrderNumber = "3" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.SCTRY" OrderNumber = "4" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.F_STATUS" OrderNumber = "5" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.LINE_NO" OrderNumber = "6" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.MEDIC" OrderNumber = "7" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.STRTMON" OrderNumber = "8" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.STRTDAY" OrderNumber = "9" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.STRTYR" OrderNumber = "10" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.STRT_DT" OrderNumber = "11" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.ONGOING" OrderNumber = "12" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.STOPMON" OrderNumber = "13" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.STOPDAY" OrderNumber = "14" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.STOPYR" OrderNumber = "15" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.STOP_DT" OrderNumber = "16" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.DOSEUNIT" OrderNumber = "17" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.ROUTE" OrderNumber = "18" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.REGIMEN" OrderNumber = "19" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.INDIC" OrderNumber = "20" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.AE_RELAT" OrderNumber = "21" Mandatory = "No"/>
			</ItemGroupDef>
			<ItemGroupDef OID = "IG.DEMOG" Name = "Demography" Repeating = "Yes" IsReferenceData = "No" SASDatasetName = "DEMOG" Domain = "Demog Domain" Origin = "Demog Origin" Role = "Demog Role" Comment = "Demog Comment">
				<ItemRef ItemOID = "IT.R_DRUG" OrderNumber = "1" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.TAREA" OrderNumber = "2" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PNO" OrderNumber = "3" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.SCTRY" OrderNumber = "4" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.F_STATUS" OrderNumber = "5" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.HT" OrderNumber = "6" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.WT" OrderNumber = "7" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.SEX" OrderNumber = "8" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.DOB" OrderNumber = "9" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.RACE" OrderNumber = "10" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.HTUNITS" OrderNumber = "11" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.WTUNITS" OrderNumber = "12" Mandatory = "No"/>
			</ItemGroupDef>
			<ItemGroupDef OID = "IG.DRUG_TRT" Name = "Treatment Assignment" Repeating = "Yes" IsReferenceData = "No" SASDatasetName = "DRUG_TRT" Domain = "Treatment Domain" Origin = "Treatment Origin" Role = "Treatment Role" Comment = "Treatment Comment">
				<ItemRef ItemOID = "IT.R_DRUG" OrderNumber = "1" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.TAREA" OrderNumber = "2" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PNO" OrderNumber = "3" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.SCTRY" OrderNumber = "4" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.F_STATUS" OrderNumber = "5" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.DRUG_TRT" OrderNumber = "6" Mandatory = "No"/>
			</ItemGroupDef>
			<ItemGroupDef OID = "IG.PHARMO1" Name = "Pharmacokinetics" Repeating = "Yes" IsReferenceData = "No" SASDatasetName = "PHARMO1" Domain = "PK Domain" Origin = "PK Origin" Role = "PK Role" Comment = "PK Comment">
				<ItemRef ItemOID = "IT.R_DRUG" OrderNumber = "1" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.TAREA" OrderNumber = "2" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PNO" OrderNumber = "3" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.SCTRY" OrderNumber = "4" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.F_STATUS" OrderNumber = "5" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKYR0" OrderNumber = "6" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKYR1" OrderNumber = "7" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKYR2" OrderNumber = "8" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKYR3" OrderNumber = "9" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKYR4" OrderNumber = "10" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKYR8" OrderNumber = "11" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKYR16" OrderNumber = "12" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKYR24" OrderNumber = "13" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.MEALYR" OrderNumber = "14" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKMON0" OrderNumber = "15" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKMON1" OrderNumber = "16" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKMON2" OrderNumber = "17" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKMON3" OrderNumber = "18" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKMON4" OrderNumber = "19" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKMON8" OrderNumber = "20" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKMON16" OrderNumber = "21" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKMON24" OrderNumber = "22" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.MEALMON" OrderNumber = "23" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKDAY0" OrderNumber = "24" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKDAY1" OrderNumber = "25" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKDAY2" OrderNumber = "26" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKDAY3" OrderNumber = "27" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKDAY4" OrderNumber = "28" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKDAY8" OrderNumber = "29" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKDAY16" OrderNumber = "30" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PKDAY24" OrderNumber = "31" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.MEALDAY" OrderNumber = "32" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.NOTDONE" OrderNumber = "33" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_DT0" OrderNumber = "34" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_DT1" OrderNumber = "35" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_DT2" OrderNumber = "36" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_DT3" OrderNumber = "37" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_DT4" OrderNumber = "38" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_DT8" OrderNumber = "39" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_DT16" OrderNumber = "40" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_DT24" OrderNumber = "41" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.MEAL_DT" OrderNumber = "42" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_TIM0" OrderNumber = "43" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_TIM1" OrderNumber = "44" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_TIM2" OrderNumber = "45" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_TIM3" OrderNumber = "46" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_TIM4" OrderNumber = "47" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_TIM8" OrderNumber = "48" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_TIM16" OrderNumber = "49" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PK_TIM24" OrderNumber = "50" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.MEALTIM" OrderNumber = "51" Mandatory = "No"/>
			</ItemGroupDef>
			<ItemGroupDef OID = "IG.PHYEX" Name = "Physical Exam" Repeating = "Yes" IsReferenceData = "No" SASDatasetName = "PHYEX" Domain = "PE Domain" Origin = "PE Origin" Role = "PE Role" Comment = "PE Comment">
				<ItemRef ItemOID = "IT.R_DRUG" OrderNumber = "1" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.TAREA" OrderNumber = "2" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.PNO" OrderNumber = "3" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.SCTRY" OrderNumber = "4" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.F_STATUS" OrderNumber = "5" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.BODY_SYS" OrderNumber = "6" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.ABNORM" OrderNumber = "7" Mandatory = "No"/>
				<ItemRef ItemOID = "IT.COMMT1" OrderNumber = "8" Mandatory = "No"/>
			</ItemGroupDef>
			<ItemGroupDef OID = "IG.REFSAMP" Name = "Sample Reference Data" Repeating = "Yes" IsReferenceData = "Yes" SASDatasetName = "REFSAMP">
				<ItemRef ItemOID = "IT.REF1" OrderNumber = "1" Mandatory = "Yes"/>
				<ItemRef ItemOID = "IT.REF2" OrderNumber = "2" Mandatory = "No"/>
			</ItemGroupDef>
			<ItemDef OID = "IT.ABNORM" Name = "Normal/Abnormal/Not Done" DataType = "integer" Length = "1" SASFieldName = "ABNORM" SDSVarName = "ABNORM SDS Variable Name" Origin = "ABNORM Origin" Comment = "ABNORM Comment">
				<Question>
					<TranslatedText xml:lang = "en">English: Normal/Abnormal/Not Done?</TranslatedText>
					<TranslatedText xml:lang = "fr">French: Normal/Abnormal/Not Done?</TranslatedText>
				</Question>
				<ExternalQuestion Dictionary = "Websters" Version = "2001 Unabridged" Code = "NormAbnormNotDone"/>
				<RangeCheck Comparator = "LT" SoftHard = "Hard">
					<CheckValue>1</CheckValue>
					<MeasurementUnitRef MeasurementUnitOID = "MU.DPML"/>
					<ErrorMessage>
						<TranslatedText xml:lang = "en">English: The value must be between 1 and 3.</TranslatedText>
						<TranslatedText xml:lang = "fr">French: The value must be between 1 and 3.</TranslatedText>
						<TranslatedText xml:lang = "es">Spanish: The value must be between 1 and 3.</TranslatedText>
					</ErrorMessage>
				</RangeCheck>
				<RangeCheck Comparator = "GT" SoftHard = "Hard">
					<CheckValue>3</CheckValue>
					<MeasurementUnitRef MeasurementUnitOID = "MU.DPML"/>
					<ErrorMessage>
						<TranslatedText xml:lang = "en">The value must be between 1 and 3.</TranslatedText>
					</ErrorMessage>
				</RangeCheck>
				<RangeCheck Comparator = "EQ" SoftHard = "Soft">
					<CheckValue>2</CheckValue>
					<MeasurementUnitRef MeasurementUnitOID = "MU.DPML"/>
					<ErrorMessage>
						<TranslatedText xml:lang = "en">English: Is the value really abnormal?</TranslatedText>
						<TranslatedText xml:lang = "es">Spanish: żIs the value really abnormal?</TranslatedText>
					</ErrorMessage>
				</RangeCheck>
				<CodeListRef CodeListOID = "CL.N_A_ND"/>
				<Role>ABNORM Role</Role>
			</ItemDef>
			<ItemDef OID = "IT.AEACTTRT" Name = "Actions taken re study drug" DataType = "text" Length = "1" SASFieldName = "AEACTTRT">
				<Question>
					<TranslatedText xml:lang = "en">Actions taken re study drug?</TranslatedText>
				</Question>
				<CodeListRef CodeListOID = "CL.AEACTTR"/>
			</ItemDef>
			<ItemDef OID = "IT.AECONTRT" Name = "Actions taken, other" DataType = "text" Length = "1" SASFieldName = "AECONTRT">
				<CodeListRef CodeListOID = "CL.AECONTR"/>
			</ItemDef>
			<ItemDef OID = "IT.AEENDAY" Name = "Stop Day - Enter Two Digits 01-31" DataType = "text" Length = "2" SASFieldName = "AEENDAY"/>
			<ItemDef OID = "IT.AEENDT" Name = "Derived Stop Date" DataType = "text" Length = "8" SASFieldName = "AEENDT"/>
			<ItemDef OID = "IT.AEENMON" Name = "Stop Month - Enter Two Digits 01-12" DataType = "text" Length = "2" SASFieldName = "AEENMON"/>
			<ItemDef OID = "IT.AEENYR" Name = "Stop Year - Enter Four Digit Year" DataType = "text" Length = "4" SASFieldName = "AEENYR"/>
			<ItemDef OID = "IT.AEOUT" Name = "Outcome" DataType = "text" Length = "1" SASFieldName = "AEOUT">
				<CodeListRef CodeListOID = "CL.AEOUT"/>
			</ItemDef>
			<ItemDef OID = "IT.AEREL" Name = "Relationship to study drug" DataType = "text" Length = "1" SASFieldName = "AEREL">
				<CodeListRef CodeListOID = "CL.AEREL"/>
			</ItemDef>
			<ItemDef OID = "IT.AESEV" Name = "Severity" DataType = "text" Length = "1" SASFieldName = "AESEV">
				<CodeListRef CodeListOID = "CL.AESEV"/>
			</ItemDef>
			<ItemDef OID = "IT.AESTDAY" Name = "Start Day - Enter Two Digits 01-31" DataType = "text" Length = "2" SASFieldName = "AESTDAY"/>
			<ItemDef OID = "IT.AESTDT" Name = "Derived Start Date" DataType = "text" Length = "8" SASFieldName = "AESTDT"/>
			<ItemDef OID = "IT.AESTMON" Name = "Start Month - Enter Two Digits 01-12" DataType = "text" Length = "2" SASFieldName = "AESTMON"/>
			<ItemDef OID = "IT.AESTYR" Name = "Start Year - Enter Four Digit Year" DataType = "text" Length = "4" SASFieldName = "AESTYR"/>
			<ItemDef OID = "IT.AETERM" Name = "Conmed Indication" DataType = "text" Length = "100" SASFieldName = "AETERM"/>
			<ItemDef OID = "IT.AE_RELAT" Name = "Check If Taken for AE" DataType = "text" Length = "1" SASFieldName = "AE_RELAT">
				<CodeListRef CodeListOID = "CL.AEREL"/>
			</ItemDef>
			<ItemDef OID = "IT.BODY_SYS" Name = "Physical Exam Body System" DataType = "integer" Length = "2" SASFieldName = "BODY_SYS">
				<CodeListRef CodeListOID = "CL.PE_TEST"/>
			</ItemDef>
			<ItemDef OID = "IT.COMMT1" Name = "Comment" DataType = "text" Length = "200" SASFieldName = "COMMT1"/>
			<ItemDef OID = "IT.DOB" Name = "Date of Birth" DataType = "text" Length = "8" SASFieldName = "DOB"/>
			<ItemDef OID = "IT.DOSEUNIT" Name = "Dose and Unit" DataType = "text" Length = "20" SASFieldName = "DOSEUNIT"/>
			<ItemDef OID = "IT.DRUG_TRT" Name = "Assigned Study Drug Treatment" DataType = "integer" Length = "1" SASFieldName = "DRUG_TRT">
				<CodeListRef CodeListOID = "CL.DRUGTRTF"/>
			</ItemDef>
			<ItemDef OID = "IT.F_STATUS" Name = "Record status, 5 levels, internal use" DataType = "text" Length = "1" SASFieldName = "F_STATUS">
				<CodeListRef CodeListOID = "CL.F_STATU"/>
			</ItemDef>
			<ItemDef OID = "IT.HT" Name = "Height" DataType = "float" Length = "4" SignificantDigits = "1" SASFieldName = "HT"/>
			<ItemDef OID = "IT.HTUNITS" Name = "Height Units" DataType = "text" Length = "2" SASFieldName = "HTUNITS"/>
			<ItemDef OID = "IT.INDIC" Name = "Conmed Indication" DataType = "text" Length = "100" SASFieldName = "INDIC"/>
			<ItemDef OID = "IT.LINE_NO" Name = "Line Number" DataType = "integer" Length = "2" SASFieldName = "LINE_NO"/>
			<ItemDef OID = "IT.MEALDAY" Name = "Meal day" DataType = "text" Length = "2" SASFieldName = "MEALDAY"/>
			<ItemDef OID = "IT.MEALMON" Name = "Meal mon" DataType = "text" Length = "2" SASFieldName = "MEALMON"/>
			<ItemDef OID = "IT.MEALTIM" Name = "Time of last meal" DataType = "text" Length = "4" SASFieldName = "MEALTIM"/>
			<ItemDef OID = "IT.MEALYR" Name = "Meal year" DataType = "text" Length = "4" SASFieldName = "MEALYR"/>
			<ItemDef OID = "IT.MEAL_DT" Name = "Date of last meal" DataType = "text" Length = "8" SASFieldName = "MEAL_DT"/>
			<ItemDef OID = "IT.MEDIC" Name = "Medication For Conmed" DataType = "text" Length = "200" SASFieldName = "MEDIC"/>
			<ItemDef OID = "IT.NOTDONE" Name = "Not done" DataType = "text" Length = "1" SASFieldName = "NOTDONE"/>
			<ItemDef OID = "IT.ONGOING" Name = "Check if Ongoing" DataType = "text" Length = "1" SASFieldName = "ONGOING"/>
			<ItemDef OID = "IT.PKDAY0" Name = "Pretreatment day" DataType = "text" Length = "2" SASFieldName = "PKDAY0"/>
			<ItemDef OID = "IT.PKDAY1" Name = "1-h day" DataType = "text" Length = "2" SASFieldName = "PKDAY1"/>
			<ItemDef OID = "IT.PKDAY16" Name = "16-h day" DataType = "text" Length = "2" SASFieldName = "PKDAY16"/>
			<ItemDef OID = "IT.PKDAY2" Name = "2-h day" DataType = "text" Length = "2" SASFieldName = "PKDAY2"/>
			<ItemDef OID = "IT.PKDAY24" Name = "24-h day" DataType = "text" Length = "2" SASFieldName = "PKDAY24"/>
			<ItemDef OID = "IT.PKDAY3" Name = "3-h day" DataType = "text" Length = "2" SASFieldName = "PKDAY3"/>
			<ItemDef OID = "IT.PKDAY4" Name = "4-h day" DataType = "text" Length = "2" SASFieldName = "PKDAY4"/>
			<ItemDef OID = "IT.PKDAY8" Name = "8-h day" DataType = "text" Length = "2" SASFieldName = "PKDAY8"/>
			<ItemDef OID = "IT.PKMON0" Name = "Pretreatment mon" DataType = "text" Length = "2" SASFieldName = "PKMON0"/>
			<ItemDef OID = "IT.PKMON1" Name = "1-h mon" DataType = "text" Length = "2" SASFieldName = "PKMON1"/>
			<ItemDef OID = "IT.PKMON16" Name = "16-h mon" DataType = "text" Length = "2" SASFieldName = "PKMON16"/>
			<ItemDef OID = "IT.PKMON2" Name = "2-h mon" DataType = "text" Length = "2" SASFieldName = "PKMON2"/>
			<ItemDef OID = "IT.PKMON24" Name = "24-h mon" DataType = "text" Length = "2" SASFieldName = "PKMON24"/>
			<ItemDef OID = "IT.PKMON3" Name = "3-h mon" DataType = "text" Length = "2" SASFieldName = "PKMON3"/>
			<ItemDef OID = "IT.PKMON4" Name = "4-h mon" DataType = "text" Length = "2" SASFieldName = "PKMON4"/>
			<ItemDef OID = "IT.PKMON8" Name = "8-h mon" DataType = "text" Length = "2" SASFieldName = "PKMON8"/>
			<ItemDef OID = "IT.PKYR0" Name = "Pretreatment yr" DataType = "text" Length = "4" SASFieldName = "PKYR0"/>
			<ItemDef OID = "IT.PKYR1" Name = "1-h year" DataType = "text" Length = "4" SASFieldName = "PKYR1"/>
			<ItemDef OID = "IT.PKYR16" Name = "16-h year" DataType = "text" Length = "4" SASFieldName = "PKYR16"/>
			<ItemDef OID = "IT.PKYR2" Name = "2-h year" DataType = "text" Length = "4" SASFieldName = "PKYR2"/>
			<ItemDef OID = "IT.PKYR24" Name = "24-h year" DataType = "text" Length = "4" SASFieldName = "PKYR24"/>
			<ItemDef OID = "IT.PKYR3" Name = "3-h year" DataType = "text" Length = "4" SASFieldName = "PKYR3"/>
			<ItemDef OID = "IT.PKYR4" Name = "4-h year" DataType = "text" Length = "4" SASFieldName = "PKYR4"/>
			<ItemDef OID = "IT.PKYR8" Name = "8-h year" DataType = "text" Length = "4" SASFieldName = "PKYR8"/>
			<ItemDef OID = "IT.PK_DT0" Name = "Pretreatment date" DataType = "text" Length = "8" SASFieldName = "PK_DT0"/>
			<ItemDef OID = "IT.PK_DT1" Name = "1-h date" DataType = "text" Length = "8" SASFieldName = "PK_DT1"/>
			<ItemDef OID = "IT.PK_DT16" Name = "16-h date" DataType = "text" Length = "8" SASFieldName = "PK_DT16"/>
			<ItemDef OID = "IT.PK_DT2" Name = "2-h date" DataType = "text" Length = "8" SASFieldName = "PK_DT2"/>
			<ItemDef OID = "IT.PK_DT24" Name = "24-h date" DataType = "text" Length = "8" SASFieldName = "PK_DT24"/>
			<ItemDef OID = "IT.PK_DT3" Name = "3-h date" DataType = "text" Length = "8" SASFieldName = "PK_DT3"/>
			<ItemDef OID = "IT.PK_DT4" Name = "4-h date" DataType = "text" Length = "8" SASFieldName = "PK_DT4"/>
			<ItemDef OID = "IT.PK_DT8" Name = "8-h date" DataType = "text" Length = "8" SASFieldName = "PK_DT8"/>
			<ItemDef OID = "IT.PK_TIM0" Name = "Pretreatment time" DataType = "text" Length = "4" SASFieldName = "PK_TIM0"/>
			<ItemDef OID = "IT.PK_TIM1" Name = "1-h time" DataType = "text" Length = "4" SASFieldName = "PK_TIM1"/>
			<ItemDef OID = "IT.PK_TIM16" Name = "16-h time" DataType = "text" Length = "4" SASFieldName = "PK_TIM16"/>
			<ItemDef OID = "IT.PK_TIM2" Name = "2-h time" DataType = "text" Length = "4" SASFieldName = "PK_TIM2"/>
			<ItemDef OID = "IT.PK_TIM24" Name = "24-h time" DataType = "text" Length = "4" SASFieldName = "PK_TIM24"/>
			<ItemDef OID = "IT.PK_TIM3" Name = "3-h time" DataType = "text" Length = "4" SASFieldName = "PK_TIM3"/>
			<ItemDef OID = "IT.PK_TIM4" Name = "4-h time" DataType = "text" Length = "4" SASFieldName = "PK_TIM4"/>
			<ItemDef OID = "IT.PK_TIM8" Name = "8-h time" DataType = "text" Length = "4" SASFieldName = "PK_TIM8"/>
			<ItemDef OID = "IT.PNO" Name = "Protocol Number" DataType = "text" Length = "15" SASFieldName = "PNO"/>
			<ItemDef OID = "IT.RACE" Name = "Ethnic Group" DataType = "text" Length = "10" SASFieldName = "RACE"/>
			<ItemDef OID = "IT.REGIMEN" Name = "Conmed Regimen" DataType = "integer" Length = "1" SASFieldName = "REGIMEN">
				<CodeListRef CodeListOID = "CL.REGF"/>
			</ItemDef>
			<ItemDef OID = "IT.ROUTE" Name = "Conmed Route" DataType = "integer" Length = "2" SASFieldName = "ROUTE">
				<CodeListRef CodeListOID = "CL.ROUTEF"/>
			</ItemDef>
			<ItemDef OID = "IT.R_DRUG" Name = "Compound" DataType = "text" Length = "8" SASFieldName = "R_DRUG"/>
			<ItemDef OID = "IT.SCTRY" Name = "Country" DataType = "text" Length = "4" SASFieldName = "SCTRY">
				<CodeListRef CodeListOID = "CL.SCTRYF"/>
			</ItemDef>
			<ItemDef OID = "IT.SEX" Name = "Gender" DataType = "text" Length = "6" SASFieldName = "SEX">
				<CodeListRef CodeListOID = "CL.SEXF"/>
			</ItemDef>
			<ItemDef OID = "IT.STOPDAY" Name = "Stop Day - Enter Two Digits 01-31" DataType = "text" Length = "2" SASFieldName = "STOPDAY"/>
			<ItemDef OID = "IT.STOPMON" Name = "Stop Month - Enter Two Digits 01-12" DataType = "text" Length = "2" SASFieldName = "STOPMON"/>
			<ItemDef OID = "IT.STOPYR" Name = "Stop Year - Enter Four Digit Year" DataType = "text" Length = "4" SASFieldName = "STOPYR"/>
			<ItemDef OID = "IT.STOP_DT" Name = "Derived Stop Date" DataType = "text" Length = "8" SASFieldName = "STOP_DT"/>
			<ItemDef OID = "IT.STRTDAY" Name = "Start Day - Enter Two Digits 01-31" DataType = "text" Length = "2" SASFieldName = "STRTDAY"/>
			<ItemDef OID = "IT.STRTMON" Name = "Start Month - Enter Two Digits 01-12" DataType = "text" Length = "2" SASFieldName = "STRTMON"/>
			<ItemDef OID = "IT.STRTYR" Name = "Start Year - Enter Four Digit Year" DataType = "text" Length = "4" SASFieldName = "STRTYR"/>
			<ItemDef OID = "IT.STRT_DT" Name = "Derived Start Date" DataType = "text" Length = "8" SASFieldName = "STRT_DT"/>
			<ItemDef OID = "IT.TAREA" Name = "Therapeutic Area" DataType = "text" Length = "4" SASFieldName = "TAREA">
				<CodeListRef CodeListOID = "CL.TAREAF"/>
			</ItemDef>
			<ItemDef OID = "IT.WT" Name = "Weight" DataType = "float" Length = "4" SignificantDigits = "1" SASFieldName = "WT"/>
			<ItemDef OID = "IT.WTUNITS" Name = "Weight Units" DataType = "text" Length = "2" SASFieldName = "WTUNITS"/>
			<ItemDef OID = "IT.REF1" Name = "Record Number" DataType = "integer" Length = "8" SASFieldName = "REF1"/>
			<ItemDef OID = "IT.REF2" Name = "Text" DataType = "text" Length = "40" SASFieldName = "REF2"/>
			<CodeList OID = "CL.AEACTTR" Name = "AE Action Taken, Study Drug" DataType = "text" SASFormatName = "AEACTTR">
				<CodeListItem CodedValue = "0">
					<Decode>
						<TranslatedText xml:lang = "en">None</TranslatedText>
						<TranslatedText xml:lang = "fr">French: None</TranslatedText>
						<TranslatedText xml:lang = "es">Spanish: None</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">Discontinued permanently</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">Reduced</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">Interrupted</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.AECONTR" Name = "AE Action Taken, Other" DataType = "text" SASFormatName = "AECONTR">
				<CodeListItem CodedValue = "0">
					<Decode>
						<TranslatedText xml:lang = "en">None</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">Medication required</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">Hospitalization required or prolonged</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">Other</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.AEOUT" Name = "AE Outcome" DataType = "text" SASFormatName = "AEOUT">
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">Resolved, no residual effects</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">Continuing</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">Resolved, residual effects</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "4">
					<Decode>
						<TranslatedText xml:lang = "en">Death</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.AEREL" Name = "AE Relationship to Study Drug" DataType = "text" SASFormatName = "AEREL">
				<CodeListItem CodedValue = "0">
					<Decode>
						<TranslatedText xml:lang = "en">None</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">Unlikely</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">Possible</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">Probable</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.AESEV" Name = "AE Severity" DataType = "text" SASFormatName = "AESEV">
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">Mild</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">Moderate</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">Severe</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "4">
					<Decode>
						<TranslatedText xml:lang = "en">Life Threatening</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.DRUGTRTF" Name = "Assigned Study Drug" DataType = "integer" SASFormatName = "DRUGTRTF">
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">Treatment A</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">Treatment B</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">Treatment C</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.F_STATU" Name = "Record Status, Internal" DataType = "text" SASFormatName = "F_STATU">
				<CodeListItem CodedValue = "S">
					<Decode>
						<TranslatedText xml:lang = "en">Source verified, not queried</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "V">
					<Decode>
						<TranslatedText xml:lang = "en">Source verified, queried</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.N_A_ND" Name = "Normal/Abnormal/Not Done" DataType = "integer" SASFormatName = "N_A_ND">
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">Normal</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">Abnormal</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">Not Done</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.PE_TEST" Name = "PE Body System" DataType = "integer" SASFormatName = "PE_TEST">
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">Head, Neck and Thyroid</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">Eyes, Ears, Nose and Throat</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">Chest</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "4">
					<Decode>
						<TranslatedText xml:lang = "en">Lungs</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "5">
					<Decode>
						<TranslatedText xml:lang = "en">Heart</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "6">
					<Decode>
						<TranslatedText xml:lang = "en">Lymph Nodes</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "7">
					<Decode>
						<TranslatedText xml:lang = "en">Abdomen</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "8">
					<Decode>
						<TranslatedText xml:lang = "en">Anorectal</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "9">
					<Decode>
						<TranslatedText xml:lang = "en">Genitalia</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "10">
					<Decode>
						<TranslatedText xml:lang = "en">Skin</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "11">
					<Decode>
						<TranslatedText xml:lang = "en">Musculoskeletal</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "12">
					<Decode>
						<TranslatedText xml:lang = "en">Neurological</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "13">
					<Decode>
						<TranslatedText xml:lang = "en">Other</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.REGF" Name = "Conmed Regimen" DataType = "integer" SASFormatName = "REGF">
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">q.d.</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">b.i.d.</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">t.i.d.</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "4">
					<Decode>
						<TranslatedText xml:lang = "en">q.i.d.</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "5">
					<Decode>
						<TranslatedText xml:lang = "en">q.o.d.</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "6">
					<Decode>
						<TranslatedText xml:lang = "en">q.h.s.</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "7">
					<Decode>
						<TranslatedText xml:lang = "en">cont. IV</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "8">
					<Decode>
						<TranslatedText xml:lang = "en">prn</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "9">
					<Decode>
						<TranslatedText xml:lang = "en">If not in list, record as Other</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.ROUTEF" Name = "Conmed Route" DataType = "integer" SASFormatName = "ROUTEF">
				<CodeListItem CodedValue = "1">
					<Decode>
						<TranslatedText xml:lang = "en">IV</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "2">
					<Decode>
						<TranslatedText xml:lang = "en">IM</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "3">
					<Decode>
						<TranslatedText xml:lang = "en">PO</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "4">
					<Decode>
						<TranslatedText xml:lang = "en">SC</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "5">
					<Decode>
						<TranslatedText xml:lang = "en">PV</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "6">
					<Decode>
						<TranslatedText xml:lang = "en">PR</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "7">
					<Decode>
						<TranslatedText xml:lang = "en">Sublingual</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "8">
					<Decode>
						<TranslatedText xml:lang = "en">Inhaled</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "9">
					<Decode>
						<TranslatedText xml:lang = "en">Topical</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "10">
					<Decode>
						<TranslatedText xml:lang = "en">If not in list</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.SCTRYF" Name = "Country" DataType = "text" SASFormatName = "SCTRYF">
				<CodeListItem CodedValue = "USA">
					<Decode>
						<TranslatedText xml:lang = "en">United States</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.SEXF" Name = "Gender" DataType = "text" SASFormatName = "SEXF">
				<CodeListItem CodedValue = "F">
					<Decode>
						<TranslatedText xml:lang = "en">Female</TranslatedText>
					</Decode>
				</CodeListItem>
				<CodeListItem CodedValue = "M">
					<Decode>
						<TranslatedText xml:lang = "en">Male</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "CL.TAREAF" Name = "Therapeutic Area" DataType = "text" SASFormatName = "TAREAF">
				<CodeListItem CodedValue = "ONC">
					<Decode>
						<TranslatedText xml:lang = "en">Oncology</TranslatedText>
					</Decode>
				</CodeListItem>
			</CodeList>
			<CodeList OID = "LOINC" Name = "LOINC Version 2.0" DataType = "text" SASFormatName = "LOINC">
				<ExternalCodeList Dictionary = "LOINC" Version = "2.0"/>
			</CodeList>
			<Presentation OID = "PRS.EN" xml:lang = "en">English</Presentation>
			<Presentation OID = "PRS.FR" xml:lang = "fr">French</Presentation>
			<Presentation OID = "PRS.ES" xml:lang = "es">Spanish</Presentation>
		</MetaDataVersion>
	</Study>
	<AdminData StudyOID = "123-456-789">
		<User OID = "USR.cdisc001" UserType = "Other">
			<FullName>Shirley Williams</FullName>
			<FirstName>Shirley</FirstName>
			<LastName>Williams</LastName>
			<Organization>CDISC</Organization>
			<LocationRef LocationOID = "LOC.CDISCHome"/>
		</User>
		<User OID = "USR.inv001" UserType = "Investigator">
			<FullName>John Smith, M.D.</FullName>
			<FirstName>John</FirstName>
			<LastName>Smith</LastName>
			<Organization>Roswell Park</Organization>
			<LocationRef LocationOID = "LOC.site002"/>
		</User>
		<User OID = "USR.inv002" UserType = "Investigator">
			<FullName>Jane Doe, M.D.</FullName>
			<FirstName>Jane</FirstName>
			<LastName>Doe</LastName>
			<Organization>Fred Hutchinson</Organization>
			<LocationRef LocationOID = "LOC.site001"/>
		</User>
		<Location OID = "LOC.CDISCHome" Name = "CDISC Headquarters" LocationType = "Other">
			<MetaDataVersionRef StudyOID = "123-456-789" MetaDataVersionOID = "v1.1.0" EffectiveDate = "20011019T10:45:57-05:00"/>
		</Location>
		<Location OID = "LOC.site001" Name = "Fred Hutchinson" LocationType = "Site">
			<MetaDataVersionRef StudyOID = "123-456-789" MetaDataVersionOID = "v1.1.0" EffectiveDate = "20011019T10:45:57-05:00"/>
		</Location>
		<Location OID = "LOC.site002" Name = "Roswell Park" LocationType = "Site">
			<MetaDataVersionRef StudyOID = "123-456-789" MetaDataVersionOID = "v1.1.0" EffectiveDate = "20011019T10:45:57-05:00"/>
		</Location>
		<SignatureDef OID = "SD.cdisc001-es" Methodology = "Electronic">
			<Meaning>Signature Meaning</Meaning>
			<LegalReason>Legal Reason</LegalReason>
		</SignatureDef>
	</AdminData>
	<ReferenceData StudyOID = "123-456-789" MetaDataVersionOID = "v1.1.0">
		<ItemGroupData ItemGroupOID = "IG.REFSAMP" ItemGroupRepeatKey = "1" TransactionType = "Insert">
			<AuditRecord>
				<UserRef UserOID = "USR.cdisc001"/>
				<LocationRef LocationOID = "LOC.CDISCHome"/>
				<DateTimeStamp>2002-04-23T08:15:47-06:00</DateTimeStamp>
			</AuditRecord>
			<ItemData ItemOID = "IT.REF1" Value = "1"/>
			<ItemData ItemOID = "IT.REF2" Value = "Sample reference data line 1"/>
		</ItemGroupData>
		<ItemGroupData ItemGroupOID = "IG.REFSAMP" ItemGroupRepeatKey = "2" TransactionType = "Insert">
			<AuditRecord>
				<UserRef UserOID = "USR.cdisc001"/>
				<LocationRef LocationOID = "LOC.CDISCHome"/>
				<DateTimeStamp>2002-04-23T08:15:47-06:00</DateTimeStamp>
			</AuditRecord>
			<ItemData ItemOID = "IT.REF1" Value = "2"/>
			<ItemData ItemOID = "IT.REF2" Value = "Sample reference data line 2"/>
		</ItemGroupData>
	</ReferenceData>
	<ClinicalData StudyOID = "123-456-789" MetaDataVersionOID = "v1.1.0">
		<SubjectData SubjectKey = "001">
			<InvestigatorRef UserOID = "USR.inv001"/>
			<SiteRef LocationOID = "LOC.site002"/>
			<StudyEventData StudyEventOID = "SE.VISIT0">
				<FormData FormOID = "FORM.DEMOG">
					<ItemGroupData ItemGroupOID = "IG.DEMOG" ItemGroupRepeatKey = "1" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:01:32-05:00</DateTimeStamp>
							<SourceID>46902604</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.HT" Value = "73"/>
						<ItemData ItemOID = "IT.WT" Value = "204"/>
						<ItemData ItemOID = "IT.SEX" Value = "M"/>
						<ItemData ItemOID = "IT.DOB" Value = "19600403"/>
						<ItemData ItemOID = "IT.RACE" Value = "Caucasian"/>
						<ItemData ItemOID = "IT.HTUNITS" Value = "in"/>
						<ItemData ItemOID = "IT.WTUNITS" Value = "lb"/>
					</ItemGroupData>
				</FormData>
				<FormData FormOID = "FORM.DRUGPHRM">
					<ItemGroupData ItemGroupOID = "IG.DRUG_TRT" ItemGroupRepeatKey = "1" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:06:32-05:00</DateTimeStamp>
							<SourceID>46878904</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.DRUG_TRT" Value = "1"/>
					</ItemGroupData>
				</FormData>
				<FormData FormOID = "FORM.PHARMVIT">
					<ItemGroupData ItemGroupOID = "IG.PHARMO1" ItemGroupRepeatKey = "1" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:11:32-05:00</DateTimeStamp>
							<SourceID>46881304</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.PKYR0" Value = "1999"/>
						<ItemData ItemOID = "IT.PKYR1" Value = "1999"/>
						<ItemData ItemOID = "IT.PKYR2" Value = "1999"/>
						<ItemData ItemOID = "IT.PKYR3" Value = "1999"/>
						<ItemData ItemOID = "IT.PKYR4" Value = "1999"/>
						<ItemData ItemOID = "IT.PKYR8" Value = "1999"/>
						<ItemData ItemOID = "IT.PKYR16" Value = "1999"/>
						<ItemData ItemOID = "IT.PKYR24" Value = "1999"/>
						<ItemData ItemOID = "IT.MEALYR" Value = "1999"/>
						<ItemData ItemOID = "IT.PKMON0" Value = "06"/>
						<ItemData ItemOID = "IT.PKMON1" Value = "06"/>
						<ItemData ItemOID = "IT.PKMON2" Value = "06"/>
						<ItemData ItemOID = "IT.PKMON3" Value = "06"/>
						<ItemData ItemOID = "IT.PKMON4" Value = "06"/>
						<ItemData ItemOID = "IT.PKMON8" Value = "06"/>
						<ItemData ItemOID = "IT.PKMON16" Value = "06"/>
						<ItemData ItemOID = "IT.PKMON24" Value = "06"/>
						<ItemData ItemOID = "IT.MEALMON" Value = "06"/>
						<ItemData ItemOID = "IT.PKDAY0" Value = "20"/>
						<ItemData ItemOID = "IT.PKDAY1" Value = "20"/>
						<ItemData ItemOID = "IT.PKDAY2" Value = "20"/>
						<ItemData ItemOID = "IT.PKDAY3" Value = "20"/>
						<ItemData ItemOID = "IT.PKDAY4" Value = "20"/>
						<ItemData ItemOID = "IT.PKDAY8" Value = "20"/>
						<ItemData ItemOID = "IT.PKDAY16" Value = "20"/>
						<ItemData ItemOID = "IT.PKDAY24" Value = "21"/>
						<ItemData ItemOID = "IT.MEALDAY" Value = "20"/>
						<ItemData ItemOID = "IT.PK_DT0" Value = "19990620"/>
						<ItemData ItemOID = "IT.PK_DT1" Value = "19990620"/>
						<ItemData ItemOID = "IT.PK_DT2" Value = "19990620"/>
						<ItemData ItemOID = "IT.PK_DT3" Value = "19990620"/>
						<ItemData ItemOID = "IT.PK_DT4" Value = "19990620"/>
						<ItemData ItemOID = "IT.PK_DT8" Value = "19990620"/>
						<ItemData ItemOID = "IT.PK_DT16" Value = "19990620"/>
						<ItemData ItemOID = "IT.PK_DT24" Value = "19990621"/>
						<ItemData ItemOID = "IT.MEAL_DT" Value = "19990620"/>
						<ItemData ItemOID = "IT.PK_TIM0" Value = "0600"/>
						<ItemData ItemOID = "IT.PK_TIM1" Value = "0700"/>
						<ItemData ItemOID = "IT.PK_TIM2" Value = "0800"/>
						<ItemData ItemOID = "IT.PK_TIM3" Value = "0900"/>
						<ItemData ItemOID = "IT.PK_TIM4" Value = "1000"/>
						<ItemData ItemOID = "IT.PK_TIM8" Value = "1400"/>
						<ItemData ItemOID = "IT.PK_TIM16" Value = "1800"/>
						<ItemData ItemOID = "IT.PK_TIM24" Value = "0600"/>
						<ItemData ItemOID = "IT.MEALTIM" Value = "0500"/>
					</ItemGroupData>
				</FormData>
				<FormData FormOID = "FORM.VITPHYEX">
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "1" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46869304</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "1"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "1"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "2" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46869504</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "2"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "1"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "3" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46869604</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "3"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "1"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "4" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46869804</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "4"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "2"/>
						<ItemData ItemOID = "IT.COMMT1" Value = "MILD WHEEZING"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "5" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46869904</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "5"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "2"/>
						<ItemData ItemOID = "IT.COMMT1" Value = "TACHYCARDIA"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "6" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46870604</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "6"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "2"/>
						<ItemData ItemOID = "IT.COMMT1" Value = "SLIGHTLY ENLARGED-NCS"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "7" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46870904</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "7"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "1"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "8" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46871004</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "8"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "3"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "9" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46871204</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "9"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "1"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "10" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46871504</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "10"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "2"/>
						<ItemData ItemOID = "IT.COMMT1" Value = "PET"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "11" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46871704</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "11"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "1"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "12" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46872504</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "12"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "1"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.PHYEX" ItemGroupRepeatKey = "13" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:16:32-05:00</DateTimeStamp>
							<SourceID>46873104</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.BODY_SYS" Value = "13"/>
						<ItemData ItemOID = "IT.ABNORM" Value = "1"/>
					</ItemGroupData>
				</FormData>
			</StudyEventData>
			<StudyEventData StudyEventOID = "SE.VISIT1">
				<FormData FormOID = "FORM.AE">
					<ItemGroupData ItemGroupOID = "IG.AE" ItemGroupRepeatKey = "1" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:21:32-05:00</DateTimeStamp>
							<SourceID>46898304</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.LINE_NO" Value = "1"/>
						<ItemData ItemOID = "IT.AETERM" Value = "HEADACHE"/>
						<ItemData ItemOID = "IT.AESTMON" Value = "06"/>
						<ItemData ItemOID = "IT.AESTDAY" Value = "10"/>
						<ItemData ItemOID = "IT.AESTYR" Value = "1999"/>
						<ItemData ItemOID = "IT.AESTDT" Value = "19990610"/>
						<ItemData ItemOID = "IT.AEENMON" Value = "06"/>
						<ItemData ItemOID = "IT.AEENDAY" Value = "14"/>
						<ItemData ItemOID = "IT.AEENYR" Value = "1999"/>
						<ItemData ItemOID = "IT.AEENDT" Value = "19990614"/>
						<ItemData ItemOID = "IT.AESEV" Value = "1"/>
						<ItemData ItemOID = "IT.AEREL" Value = "0"/>
						<ItemData ItemOID = "IT.AEOUT" Value = "1"/>
						<ItemData ItemOID = "IT.AEACTTRT" Value = "0"/>
						<ItemData ItemOID = "IT.AECONTRT" Value = "1"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.AE" ItemGroupRepeatKey = "2" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:21:32-05:00</DateTimeStamp>
							<SourceID>46903404</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.LINE_NO" Value = "2"/>
						<ItemData ItemOID = "IT.AETERM" Value = "CONGESTION"/>
						<ItemData ItemOID = "IT.AESTMON" Value = "06"/>
						<ItemData ItemOID = "IT.AESTDAY" Value = "11"/>
						<ItemData ItemOID = "IT.AESTYR" Value = "1999"/>
						<ItemData ItemOID = "IT.AESTDT" Value = "19990611"/>
						<ItemData ItemOID = "IT.AESEV" Value = "1"/>
						<ItemData ItemOID = "IT.AEREL" Value = "0"/>
						<ItemData ItemOID = "IT.AEOUT" Value = "2"/>
						<ItemData ItemOID = "IT.AEACTTRT" Value = "0"/>
						<ItemData ItemOID = "IT.AECONTRT" Value = "1"/>
					</ItemGroupData>
				</FormData>
				<FormData FormOID = "FORM.CONMED">
					<ItemGroupData ItemGroupOID = "IG.CONMED" ItemGroupRepeatKey = "1" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:26:32-05:00</DateTimeStamp>
							<SourceID>46896304</SourceID>
						</AuditRecord>
						<ItemData ItemOID = "IT.R_DRUG" Value = "SDP"/>
						<ItemData ItemOID = "IT.TAREA" Value = "ONC"/>
						<ItemData ItemOID = "IT.PNO" Value = "143-02"/>
						<ItemData ItemOID = "IT.SCTRY" Value = "USA"/>
						<ItemData ItemOID = "IT.F_STATUS" Value = "V"/>
						<ItemData ItemOID = "IT.LINE_NO" Value = "1"/>
						<ItemData ItemOID = "IT.MEDIC" Value = "TYLENOL"/>
						<ItemData ItemOID = "IT.STRTMON" Value = "06"/>
						<ItemData ItemOID = "IT.STRTDAY" Value = "10"/>
						<ItemData ItemOID = "IT.STRTYR" Value = "1999"/>
						<ItemData ItemOID = "IT.STRT_DT" Value = "19990610"/>
						<ItemData ItemOID = "IT.STOPMON" Value = "06"/>
						<ItemData ItemOID = "IT.STOPDAY" Value = "14"/>
						<ItemData ItemOID = "IT.STOPYR" Value = "1999"/>
						<ItemData ItemOID = "IT.STOP_DT" Value = "19990614"/>
						<ItemData ItemOID = "IT.DOSEUNIT" Value = "325/MG"/>
						<ItemData ItemOID = "IT.ROUTE" Value = "3"/>
						<ItemData ItemOID = "IT.REGIMEN" Value = "8"/>
						<ItemData ItemOID = "IT.INDIC" Value = "HEADACHE"/>
						<ItemData ItemOID = "IT.AE_RELAT" Value = "0"/>
					</ItemGroupData>
					<ItemGroupData ItemGroupOID = "IG.CONMED" ItemGroupRepeatKey = "2" TransactionType = "Insert">
						<AuditRecord>
							<UserRef UserOID = "USR.inv001"/>
							<LocationRef LocationOID = "LOC.site002"/>
							<DateTimeStamp>2002-02-04T14:26:32-05:00</DateTimeStamp>
							<SourceID>46901404</SourceID>
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